510(k) K231020

Alinity c Tricyclic Antidepressants Reagent Kit by Microgenics Corporation — Product Code LFH

K231020 is an FDA 510(k) premarket notification submitted by Microgenics Corporation for the device "Alinity c Tricyclic Antidepressants Reagent Kit". The FDA issued a decision of Substantially Equivalent on November 17, 2023. The device falls under product code LFH (U.V. Spectrometry, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. Microgenics Corporation has at least 10 other 510(k) clearances on record.